Antimicrobial resistance

The emerging and steady increase of microbes that are resistant to antimicrobial treatments has become a global public health concern that threatens the effective treatment of infectious diseases. Combatting this threat, particularly resistance to antibiotics, is a high priority for the European Medicines Agency (EMA) and the European medicines regulatory network.

Recent activities involving EMA

In November, EMA published a meeting report on its joint info session with ECDC involving EMA's working parties for patients and consumers and for healthcare professionals held in September, highlighting the work of EU institutions and agencies, Member States and the WHO in the fight against antimicrobial resistance.

In October, EMA, EFSA and ECDC published a list of harmonised outcome indicators to enable Member States to assess their progress in reducing the use of antimicrobials and combatting antimicrobial resistance in both the human and animal sectors.

Antimicrobial resistance is when a microbe evolves to become more or fully resistant to antimicrobials which previously could treat it. Antimicrobials include antibiotics, which kill or inhibit the growth of bacteria.

A well-known example of a bacterium that is resistant to a number of antibiotics is meticillin-resistant Staphylococcus aureus (MRSA), which has caused infections that are difficult to treat across the European Union (EU).

Infections by multidrug-resistant bacteria are estimated to cause 25,000 deaths in the EU every year. Amtimicrobial resistance also places a tremendous burden on healthcare systems and society, with an annual cost due to healthcare expenditures and productivity losses estimated at approximately €1.5 billion in the EU.

Although the development of resistance occurs naturally when microorganisms replicate themselves erroneously or when resistant traits are exchanged between them, the use and misuse of antimicrobials accelerates the emergence of resistant strains.

The lack of new antibiotics entering the market exacerbates the problem.

Antimicrobial resistance affects both humans and animals and resistance can also spread from animals to humans through the food chain or direct contact.

Agency role

EMA plays a vital role in the global response to the threat of antimicrobial resistance, by:

Update: At a third meeting between the three agencies in October 2017, they agreed to align how clinical trials should be designed to study the effects of new antibiotics in certain indications, such as uncomplicated gonorrhoea or uncomplicated urinary tract infections.

They also committed to working together to explore how to better streamline paediatric development of new antibacterial agents. For more information, see:

At their second meeting in April 2017, the agencies agreed to align their data requirements for certain aspects of the clinical development of new antibiotics in order to stimulate the development of new treatments. For more information, see:

The agencies first met in September 2016 to discuss regulatory approaches for the evaluation of antibacterial agents.

They concluded that a comprehensive and multifaceted response is needed to encourage and accelerate development of new antibacterial medicines, and agreed to explore common regulatory approaches. For more information, see: